Actively Recruiting
A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-05-13
36
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
CONDITIONS
Official Title
A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and understood study details
- Male or female aged 18 to 65 years inclusive
- Body mass index between 18 and 30 kg/m2 inclusive
- Male weight at least 50.0 kg; female weight at least 45.0 kg
- Glomerular filtration rate (GFR) of 60-89 mL/min for mild impairment
- GFR of 30-59 mL/min for moderate impairment
- GFR of 15-29 mL/min for severe renal impairment
You will not qualify if you...
- History of allergies such as asthma, urticaria, eczema, or allergies to any drug, food, or study drug components
- Cardiogenic shock, severe conduction block, sick sinus syndrome, severe heart failure (NYHA III-IV), persistent rapid arrhythmia, serious ventricular tachycardia, significant T-wave changes, myocardial infarction, or angina
- Malignant tumors or history of tumors within 5 years prior to screening (except treated non-recurrent skin non-melanomas and cervical intraepithelial neoplasia)
- History of gastric or intestinal surgery affecting drug absorption
- Severe trauma or major surgery within 3 months prior to screening or planned surgery during the trial
- Participation in another clinical trial or use of investigational drugs within 3 months or within five half-lives
- Blood donation of 400 mL or more within 4 weeks, severe blood loss, or blood transfusion within 8 weeks
- Receipt of live (attenuated) vaccines within 4 weeks before or planned during the trial
- Difficulty with blood collection or history of fainting at needle sight
- Renal replacement therapy within 3 months before or during the trial
- Poorly controlled underlying diseases causing chronic kidney disease, like diabetes with HbA1c over 10% or hypertension with systolic BP over 180 mmHg and diastolic BP over 120 mmHg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
Research Team
Y
Ying Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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